MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, 8 FLUTE 4.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BURR, ROUND, 8 FLUTE 4.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a knee arthroscopy procedure, the round burr, ar-8400rbe, was being used for a notchplasty during an acl reconstruction.During use, metal debris was being discharged from the end of the burr into the knee.Or staff discarded the burr into the sharps container.Most of the debris was cleaned out with a shaver and a second round burr, ar-8400rbe, was opened to complete the case.During use, this round burr, with the same lot number as the first, also discharged metal debris.Again, the shavings were removed via shaver and the case was completed with a third round burr, ar-8400rbe, from a different lot number.Additional information provided 01/06/2020: patient's bone was hard.No pump was used during case; it was all gravity tubing.There was no interruption of fluid during use.The rep cannot confirm for sure that there was debris left behind.The staff and surgeon stated that they got the debris they could see out.
Additional Manufacturer Narrative
Complaint confirmed.The returned round burr ar-8400rbe was visually inspected, showing horizontal grooves along the collar of the inner diameter of the outer tube.This is consistent with a site of metal debris production.Among the most common causes for this type of occurrence, are user applied mechanical damage, such as through prying/leveraging of the device against bone or hard tissue during use.

• Brand Name: BURR, ROUND, 8 FLUTE 4.0MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9585896
• Report Number: 1220246-2020-01576
• Device Sequence Number: 14037285
• Product Code: GFF
• UDI-Device Identifier: 00888867043626
• UDI-Public: 00888867043626
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: BURR, ROUND, 8 FLUTE 4.0MM X 13CM
• Device Catalogue Number: AR-8400RBE
• Device Lot Number: 10387067
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other